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Research

Photo for REVIVAL Pilot

REVIVAL Pilot

Official Title

Ross for Valve replacement in AduLts (ReVIvAL)

Status

Ongoing

Overview

In patients undergoing AVR for the treatment of aortic valve disease, does the Ross procedure result in superior outcomes when compared to conventional AVR techniques, including stented or stentless bioprostheses and mechanical aortic valves, with respect to survival free of life-threatening valve-related complications (life-threatening bleeding, systemic thromboembolism, valve thrombosis, and operated-on valve re-intervention) within the first eight years post-operatively?

Study Design

An international multicenter trial of surgical AVR in 1047 young adults (18-60 years of age) undergoing the Ross procedure versus one of the alternative approaches (mechanical versus bioprosthesis versus stentless porcine root) with expertise-based randomization.

Primary Endpoint

The outcome measures of the pilot phase, in order of importance, are: 1) To evaluate the capacity to enroll a mean of 6 patients per year per center; 2) To validate the assumption of greater than 90% compliance with allocation; 3) To validate the proportion of mechanical (65%) versus biological (35%) valves in the conventional arm.

Number of Patients

60

Number of Sites

7

Number of Countries

2

Study Period

2017-2020

Principal Investigator

Richard Whitlock

Program Manager

Shirley Pettit

Research Coordinator

Kate Brady